The goal of this clinical trial is to learn if troxerutin works to prevent thromboticevents in mild or severe COVID-19 patients. It will also learn about the safety oftroxerutin. The main questions it aims to answer are: - Does troxerutin lower the number of thrombotic events in participants? - What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.Participants will: - Take troxerutin or a placebo every day for 7 days. - Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests - Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia
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Drug: Troxerutin
Oral troxerutin tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
Drug: Placebo
Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet) orally, twice daily
Drug: placebo + low molecular weight heparin
2000 IU LMWH once a day + Oral placebo tablets, with a dosage of 3 tablets (60 mg/tablet)
orally, twice daily
Drug: troxerutin + low molecular weight heparin
2000 IU LMWH once a day + Oral troxerutin tablets, with a dosage of 3 tablets (60
mg/tablet) orally, twice daily
Inclusion Criteria:
As long as the patient meets all of the following conditions, adult patients aged 18 and
above are eligible for admission:
► COVID-19 patients, defined as: positive RT-PCR (upper respiratory tract or lower
respiratory tract) for SARS-CoV-2.
Mild COVID-19 patients are defined as:
Symptomatic patients meeting the case definition for COVID-19 without evidence of hypoxia
or pneumonia. Common symptoms include fever, cough, fatigue, anorexia, dyspnea, and
myalgia. Other nonspecific symptoms include sore throat, nasal congestion, headache,
diarrhea, nausea/vomiting, and loss of smell/taste.
Severe COVID-19 patients are defined as:
Adolescents or adults with clinical signs of pneumonia (i.e., fever, cough, dyspnea,
tachypnea) plus one of the following:
1. Respiratory rate ≥30 breaths/min
2. Severe respiratory distress
3. Oxygen saturation (SpO₂) ≤90% in room air
4. Progressive deterioration of clinical symptoms with lung imaging showing significant
progression of lesions (>50%) within 24 to 48 hours.
- Written informed consent provided according to Chinese law (by the patient,
legal guardian, or deferred consent in emergencies).
Exclusion Criteria:
Patients with any of the following conditions will be excluded from the study:
- Pregnant or lactating women.
- Postpartum (within 6 weeks).
- Extreme weight (100 kilograms).
- Clinical need for heparin therapy.
- Bleeding related to coagulation disorders, acute clinically significant bleeding,
active gastrointestinal ulcers, or any organic lesions with high bleeding risk.
- Platelet count <50 x 10^9/L.
- Surgery within the last 15 days, or within 24 hours after spinal or epidural
anesthesia.
- History of intracranial hemorrhage, large ischemic stroke, known intracranial
malformation or tumor, acute infective endocarditis.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Iodine allergy.
- Long-term use of oxygen supplementation.
- Moribund patients or those expected to die during the current hospitalization due to
underlying disease.
- Patients deprived of freedom and those undergoing institutional psychiatric care.
- Ward of the state or under guardianship.
- Participation in other anticoagulant intervention studies.
Shaoxing central hospital
Shaoxing, Zhejiang, China
Investigator: Xu Li, Doctor
Contact: 13811635032
lixu@westlake.edu.cn
Xu Li, PhD
13811635032
lixu@westlake.edu.cn
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